QC测试所涉及的设备和仪器清单。清单应包括相关设备和仪器的制造商和型号。

9.2. Other relevant documentation may include, on a case-by-casebasis as required, drawings; manuals; maintenance procedures and records;calibration procedures and records; as well as procedures such as equipmentset-up, operation and cleaning.

其他相关文件可能包括图纸(视具体情况而定);手册;维护程序和记录;校正程序和记录;以及设备设置、操作和清洗等的程序。

9.3. A review and a side-by-side comparison of equipment andinstruments of the SU and RU should be carried out in terms of their workingprinciple, make and models.

对转移方和接收方的设备和仪器进行工作原理、制造、型号等方面的审查和平行对比。

9.4. Where the review and comparison identify any gaps ordifferences, appropriate action should be taken. This may include theadaptation of existing equipment or acquisition of newequipment. Such action should be taken by following a changemanagement procedure which should be documented.

当审查和比较发现任何差距或差异时，应采取适当的措施。可能包括改造现有设备或购置新设备。这些措施应通过变更管理程序来进行，并应形成文件。

9.5. Production volumes and batch sizes at the SU and RU should becompared. Where batch sizes are different, the impact should be assessed andthe appropriate action planned and taken. Other factors relating to equipmentto be reviewed may include: